Üzüm üzüme bakarak, Türkler ABD ye bakarak kararırlar!

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Acı İlaç

İlaç konusunda sahtekarlık hemen her ülkede gittikçe artan bir hızla devam etmekte. Defalarca söylediğimiz gibi ilaç sanayiinde yeni molekül keşfi azaldıkça sahtekarlık artmakta ve bazı firmalar hissedarlarını tatmin için bu yolu tercih etmekte. Bunun son örneklerinden birisi dünyanın en büyük jenerik ilaç firmalarından Hintli Ranbaxy’nin yaptıkları. Ranbaxy’nin ABD de kurtlar sofrasında kendine yer bulmak için sahte biyoeşdeğerlik dosyaları hazırlayarak bir taraftan FDA’i diğer taraftan hastaları kandırdığı iddia edilmekte. Bununla işgili olarak ABD adalet bakanlığı Ranbaxy hakkında tahkikat başlatırken, diğer taraftan ABD temsilciler meclisi FDA hakkında soruşturma başlatmıştır (detaylar haberler bölümünde). Hatırlanacağı gibi benzer olay bundan birkaç sene önce Türkiyede de olmuş (AllPharma olayı) ama bazı biyoeşdeğerlik çalışmalarının tekrarlatılması dışında, yapanların yanına kar kalmıştı.

ABD de 1863 de, sivil savaşın en şiddetli olduğu dönemde, “False Claims Act, FCA-sahte hak talep etme yasası” (daha sonra Lincoln kanunu olarak anılmış) ve vatandaşlara devleti dolandıranlara karşı dava açma hakkı tanınmıştır. Yani kişiler devlet adına, sahtekarlık yaparak devleti zarara uğratanlar hakkında dava açabilmekte ve davayı kazandıklarında elde edilen tazminatın %10-30’un kendilerine alabilmekte.  Buna “Qui Tam” hakkı denilmekte. Qui Tam Latince “Qui tam pro domino rege quam pro si ipso hac parte sequitur” un kısaltması olup “her kim kırak adına birisini dava ederse ayni zamanda kendisi içinde dava etmiş sayılır” demekmiş…         

Yolsuzlukları ihbar eden kişilere “Relator veya whistleblower - muhbir veya çalıştığı bölümdeki yolsuzlukları kamuoyuna duyuran devlet memuru” denilmekte. Yenilenen FCA kanunda cezalarda artırıma gidilmiş ve sahtekarların devlete verdikleri zararın 3 mislini ödemeleri şartı getirilmiştir. Türkiyede de 1262 sayılı kanunda cezalar benzer şekilde belirtilmiş (..temin etmek istediğimenfaatin 2 mislinden az olmamak üzere.. gibi) fakat bu sene yapılan değişiklikle bu madde sulandırılmış ve sahtekarlıkların cezaları hafifletilmiştir, herkes gider Mersine biz gideriz tersine… (Madde 18:Müstahzarları taklit ederek bunların tedavi vasıflarını azaltacak veya kaybedecek surette imal edenler veya bu suretle imal edildiğini bilerek satan, satılığa arzeden veya sattıranlar üç aydan bir seneye kadar hapis ve temin ettikleri veya etmek istedikleri menfaatin iki mislinden aşağı olmamak üzere ağır para cezasiyle cezalandırılırlar.Şu kadar ki bu para cezası 200 liradan aşağı olamaz.Tekkerrürü halinde ruhsatı geri alınır.

Değişik(08/02/2008 – 5728/45.md):Müstahzarları taklit ederek bunların tedavi vasıflarını azaltacak veya kaybedecek ya da kullananların sıhhatine az veya çok zarar verecek surette imal edenler veya bu suretle imal edildiğini bilerek satan, satışa arzeden veya sattıranlar, Türk Ceza Kanunu veya diğer ilgili kanun hükümlerine göre cezalandırılır.)

Sonuç olarak ABD de “FCA” kanunu sayesinde devlet 1986 dan beri 20 milyar dolar kazanmıştır. 2007 Yılında ABD 2 milyar doları geri almış ve bunun 1.45 milyar doları Qui Tam muhbirleri sayesinde olmuştur. 2007 deki olaylara sağlıkla ilgili firmalardan bazı örnekler:

-          328 Milyon dolar BMS ve onun jenerik bölümü Apothecondan, kanunsuz fiyatlandırma ve pazarlama faaliyetleri dolayısı ile

-          311 Milyon dolar 4 kalça ve diz protez firmasından (Zimmer, Inc., Depuy Orthopaedics, Inc., Biomet Inc. and Smith & Nephew, Inc) ortopedislere rüşvet vermekten

-          180 Milyon dolar Sanofi-Aventisten, ilaç fiyatlarını şişirmekten (muhbir 33 milyon dolar almıştır)

-          İllinois baş savcısı 48 ilaç firması hakkında ilaç fiyatlarınde sahtekarlık yaptıkları için dava açtı (Medicare hastaları yüzmilyonlarca dolar fazla ilaç parası ödemiş), Alabama da 79 ilaç firması için benzer dava açıldı, 19 eyalette davalar birbirini takip etmekte.. Daha fazla bilgi isteyenler aşağıdaki tabloya bakınız!

Benzer olaylar bundan birkaç gün önce sayın Çalışma Bakanı tarafından açıklandı ve sosyal güvenlik kurumunun hastaneler tarafından milyonlarca YTL dolandırıldığını açıkladı. Bekleyelim görelim bakalım bunlar herzaman olduğu gibi yapanların yanına kar mı kalacak yoksa devletin zararları geri alınacak mı?.. Ya 2 milyar dolarlık ilaç israfına kim dur diyecek????

[email protected] 

 

Company

Amount in Millions $

Date

Nature of the fraud

Medicare

Medicaid

Bristol-Myers Squibb

328

9/28/2007

A total $515 million settlement, with $328 million to be paid under the Federal False Claims Act, and the state's getting $187 million.  Fraud charges included off-label marketing,  kickbacks, AWP drug pricing violations and several other frauds involving 50 drugs and a total of seven qui tam cases.

X

X

Amerigroup

172

3//14/2007

Judgment for $334 million including penalties.  Amerigroup cherry-picked patients in violation of its HMO Medicaid contract, purposely avoided women in their third trimester of pregnancy because they cost more to insure. Note that this judgment is on appeal and reflects a $190 million penalty on top of a $144 million jury verdict.

 

 

Combined settlement with four orthotics companies: Smith & Nephew, Biomet, Zimmer, DePuy (Johnson & Johnson)

310

9/27/2007

$310 million total settlement of broad practice of kickback in the orthotics industry.  Zimmer to pay 169.5 million, DePuy to pay $84.7 million, Smith and Nephew to pay $28.9 million, Biomet to pay $26.9 million.  Stryker agreed to be monitored, but has entered no civil settlement.

 

 

Aventis (sanofi-aventis)

180

9/17/2007

Medicaid Average Wholesale Price case involving the anti-nausea drug Anzemet. Total settlement was for $190 million

 

 

Medco

155

10/24/2006

Shorting prescriptions,  canceling  prescriptions to avoid paying non-performance penalties, soliciting and accepting kickbacks from pharmaceutical manufacturers to favor their drugs, and paying kickbacks to health plans to obtain business.

X

X

Purdue Pharma

140.5

5/10/2007

Company "mislabeled" the drug saying it was less addictive than it was.  This is a $634.5 million settlement, with $276 million to be forfeited to the United States, $160 million allocated to federal and state government agencies to resolve false claims for government healthcare programs and $130 million will go to resolving private civil claims. Of the 160 million to go to State and Federal FCA claims, $19.5 million is to go to the states.
 

 

 

Omnicare / Specialized Pharmacy Services (Michigan)

52.5

10/5/2006

Improper billing, failure to credit Medicare for returned drugs, billing drugs for dead patients.

 

X

Omnicare

49.5

11/14/2006

Illegal switching of generic pill to capsule forms of  Zantac (ranitidine) in nursing homes and other facilities.  

 

 

InterMune, Inc.

36.8

10/27/2006

Illegal off-label promotion of  Actimmune.

X

X

Lourdes Perez, Provident Home Health Care Services Inc. and Tri-Regional Home Health Care Inc.

33.8

10/11/2006

Medicare "bill mill" in which Medicare was billed for patients who were not homebound and for services her companies did not perform, creating false medical records to support the claims.

X

 

Maximus Inc.

30.5

7/24/2007

Maximus billed DC Medicaid for targeted case management services that it either did not provide or had no records for.

 

 

Robert I. Bourseau, Dr. Rudra Sabaratnam, and their two single-employee corporations, RIB Medical Management Services, Inc., and Navatkuda, Inc.,

23.8

10/2/2006

Used false cost reports to bill Medicare for unreimbursable services at the Chula Vista psychiatric hospital formerly known as Bayview Hospital & Mental Health Systems. 

X

 

Harris County Hospital District

15.5

3/28/2007

Medicare Secondary Payer violations billing Medicaid for patients under custody of law enforcement.

 

 

Larkin Community Hospital in Miami and its current and former owners, Dr. Jack Michel, Dr. James Desnick, Morris Esformes and Philip Esformes

15.4

11/30/2006

Kickbacks

X

X

Jackson Memorial Health System

14.25

12/20/2006

Jackson Memorial was deliberately making use of unallowable or reopened cost reports, getting wrongful overpayments as a result.

X

 

Cell Therapeutics

10.5

4/18/2007

Off-label marketing of Trisenox billed to Medicare.

 

 

Intergris Baptist Medical Center

10

11/28/2006

Inflated costs for organ transplants

 

 

Medicis Pharmaceutical

9.8

5/8/2007

Off-label marketing:  Company promoted the use of a topical anti-fungal, Loprox, for diaper rash on children under the age of 10, without approval by the Food & Drug Administration.

 

 

American Medical Response Inc.

9

10/5/2006

Ambulance services fraud.

X

 

SCCI Health Services Corporation, and its subsidiary, SCCI Hospital Ventures Inc

7.5

1/7/2007

Kickback and self-referral (Stark violations)

X

 

Raritan Bay Medical Center

7.5

3/16/2007

Purposefully inflated outlier charges for inpatient and outpatient care to make these cases appear more costly than they actually were.

 

 

Atlanta's Northside Hospital

5.75

10/20/2006

Kickbacks

 

 

Keystone Mercy Health Plan

5

10/27/2006

Medicaid HMO Kept Medicaid overpayments

 

X

St. Elizabeth Regional Medical Center (NE)

4

10/31/2006

Used false cost reports to overbill l Medicare for neonatal and burn units.

 

 

Scooter Stores

4

 5/14/2007

Settlement includes $4 million in cash and $13 million in foregone Medicare payments to settle charges the company  billed Medicare medically unnecessary power wheelchairs.

 

 

HealthSouth Corporation

4

11/3/2006

HealthSouth submitted  fraudulent Medicare claims for prosthetic and orthotic devices - such as artificial limbs and braces - used to treat HealthSouth hospital inpatients

X

 

Our Lady of Lourdes Regional Medical Center

3.8

5/9/2007

Billing Medicare, Medicaid and private insurance providers $2.5 million for unnecessary cardiac procedures, such as angiograms and angioplasties, on more than 70 patients.
 

 

 

Orphan Medical/ Jazz Pharmaceuticals Inc

3.75

7/13/2007

Aggressive marketing of Xyrem (GBH, the "date rape" drug) for unapproved use.  Part of a total settlement of $20 million, including criminal.

 

 

Cabrini Medical Center

3.4

3/29/2007

Kickbacks billed as administrative services for referral of patients.

 

 

Korrect Optical

3.25

1/25/2007

Korrect Optical submitted false claims to the Department of Veteran Affairs ( VA )through ophthalmic prescriptions for eyewear for veterans.

 

 

Dr. Daniel Nixon and other board members of the Institute for Cancer Prevention, Tatum, LLC and Weiser, LLP

3.2

1/17/2007

Unlawful receipt and use of federal grant money.

 

 

Dey

2.8

4/26/2007

Settle charges of price inflation and defrauding Mass.  Medicaid program (AWP).

 

 

Rural/Metro Corporation

2.5

6/11/2007

Kickback for referrals

 

 

David Rommel

2.48

11/13/2006

Dental practice fraud.  Won by summary judgment.

 

 

Danbury Hospital (CN)

2.4

10/27/2006

Self-reported upcoding for  septicemia, respiratory failure, respiratory infections and inflammations.

X

 

University of Miami Medical School

2.2

12/27/2006

UM sometimes billed for critical care services when patients were not critically ill or where critical services were not rendered.

X

X

Loma Linda Behavioral Medicine Center (Loma Linda BMC) in Redlands

2

 4/26/2007

Fraudulently overbilled federal health insurance programs by manipulating cost reports.

 

 

O'Hara Regional Center for Rehabilitation, Health Care Management Partners, ORCR Inc., Solomon Health Management, Solomon Health Services

1.9

10/5/2006

Abuse and neglect and substandard nursing home services.

 

X

Emeritus Corp

1.86

8/30/2007

False and inaccurate billing to the Texas Medicaid program.

 

 

Crawford and Company

1.36

10/11/2006

Billing the government for health care services to federal employees at rates set by Crawford managers, rather than billing the actual time spent performing that service.

 

 

Ciena Healthcare Management

1.25

8/20/2007

Improperly billed Medicaid and Medicare for inadequate care of and services to residents at four metro Detroit nursing homes.

 

 

Lancaster Community Hospital

1.2

6/8/2007

Knowingly overbilled Medicare for physical therapy costs.

 

 

Lakewood Cheder School

1.2

10/31/2006

False information to obtain funds for preschool lunch program.

 

 

Robert E. Eberhart and Jonathan Holzaepfel, orthopedic surgeons and partners in Seacoast Trust, and Thomas King

1

3/8/2007

HealthSouth paid higher than normal rent equivalent to income from referrals made by the doctors

 

 

Parkway Hospital, Inc

1

 8/14/2007

Inflated hospital costs reports.

 

 

Environmental Management Inc.

1

4/2/2007

Overbilling and illegal disposal of chemicals in methamphetamine lab cleanups for DEA.

 

 

Julio C. Melo, M.D.,

0.984

7/23/2007

Billed Medicare for Evaluation and Management services that exceeded the number of hours  there were in a day.

 

 

RightCHOICE Managed Care Inc.

0.975

1/31/2007

RightCHOICE paid higher fees to physicians serving government0insured patients than for other plans.

 

 

Comprehensive Cancer Centers

0.9

11/8/2006

Upcoding led to overbilling of Medicare for CCC services at Desert Regional Medical Center (owned by Tenet)

X

 

Iftakhar Khan and Amjad Khan

0.825

1/9/2007

Owners of Livonia-based Michigan Rehabilitation and Pain Management fraudulently billed Medicare.

X

 

Green Valley Pavilion, LLC

0.55

5/14/2007

Forging and altering patient charts to maximize reimbursement from Delaware's Medicaid Program

 

 

Oregon Imaging Center

0.51

12/12/2006

Tests not ordered by doctor.

 

 

John Dempsey Hospital

0.475

6/27/2007

Overbilled Medicare for chemotherapy treatment.

 

 

Colquitt Regional Medical Center

0.475

3/5/2007

Overcharged the government for services through CRMC's Home Health Office in Sylvester, GA

X

X

Hillsboro Area Hospital, in Hillsboro, Ill.

0.3

2/7/2007

Over billing for the treatment of Medicare beneficiaries who were diagnosed with pneumonia, sepsis, and renal failure.

X

 

Beacon Ambulance Company.

0.219

3/29/2007

Use of one basic technician and a single Paramedic on ambulance run, and billing for two Paramedics.

 

 

Riverview Cancer Center

0.165

10/5/2006

Upcoding and services not provided

 

 

Dr. Roberto Ramirez

0.03

12/21/2007

False dental billing

X

X

TOTAL

2117.20